1. What is a teletrial?
The Australian Teletrial Program (2022) provides the following definition:
A teletrial is a group of clinical trial sites that work together to conduct a clinical trial under the supervision of a Primary Site.
A teletrial uses telehealth technology to communicate between the Primary Site and Satellite Site/s and enables delivery of aspects of a clinical trial closer to home for patients, particularly in regional, rural and remote locations. A Principal Investigator supervises Associate Investigator/s to conduct a clinical trial at a Satellite Site which is geographically remote from the Principal Investigator’s Primary Site.
The Principal Investigator remains responsible for the trial. A detailed Supervision Plan is required, in addition to a Delegation Log required by ICH GCP for all Satellite Sites regardless of experience. Trial participants may have trial visits at both the Primary and Satellite Sites, as determined by the Protocol and Supervision Plan.
Decentralized Clinical Trial (DCT)
The term Decentralized Clinical Trial (DCT) is often used by sponsors as an umbrella term. Teletrials are a 'sub-component' or a type of DCT.
This idea and model do not specify the difference between a Primary and Satellite Site but conceive of a spectrum of activities that may be interpreted according to sponsors' and clinicians' needs. Essentially very similar to Teletrials but there are not enough published examples yet to determine fixed models.
McKinsey & Company Decentralized Trials, Article 2021
Position Paper on decentralised clinical trials (DCTs) with medicinal products in Switzerland
Virtual Clinical Trials
A fully virtual clinical trial is one that is completely technology-based and can include those run by registry searches and data mining. That means there are no traditional sites, no physical locations used, and no face-to-face interactions. Actual participants may be involved but all interaction is via websites, phones, apps, watches, and e-diaries.
Benefits of the Teletrial model
For Patients:
- Local support
- Being able to participate in a clinical trial with family, community and local healthcare support
- Equitable access
- Equity of access for all Australians to clinical trials and improved access to new therapies
- Reduced time and costs
- Reduction in travel for patients and accommodation costs
- Higher satisfaction
- A patient-centric approach gives participants more choice in their clinical trial experience, which yields higher satisfaction scores (Medidata Solutions, Whitepaper 2021)
For Sponsors:
- Increased trial awareness
- Without geographic or travel limitations, participants can enrol in trials outside their local area
- Recruitment and retention
- Potential for improvement in participant recruitment and retention, and increased diversity of participants in clinical trials
- Enhanced scientific generalisability of study outcomes
- Increased potential to recruit in rare and less common cancer studies through greater access for patients with rare cancers via the availability of more trial sites
- Higher retention
- A patient-centric approach gives participants more choice in their clinical trial experience, which yields higher satisfaction scores (Medidata Solutions, Whitepaper 2021)
Sponsors' engagement with the teletrial model (DCTs)
Major regulators from the USA and Europe are actively engaging with sponsors to encourage and support flexible approaches to trials either as teletrials or DCTs. Recent position papers and policy directions from conferences have focused on making trials more patient-centred.
DCTs in 2023: New year’s resolutions for decentralised clinical trials
Year in review: who were the main DCT players in 2022? (clinicaltrialsarena.com)
Who and what is at the crest of the clinical trial decentralisation wave? Feb 2022
Background to Teletrial model in Australia
The Australasian Teletrial Model released in September 2016 was developed by the Clinical Oncology Society of Australia (COSA) Regional and Rural Group in consultation with clinical trial sponsors, clinicians, health administrators and regulatory bodies.
COSA Teletrial Model September 2016
The term teletrial was codified in the National Principles for Teletrials in Australia in 2021.
National Principles for Teletrials in Australia
Links to further information
Click on the headings below to access further resources:
https://www.cosa.org.au/media/hallsjb3/cosa-teletrial-model-final-19sep16.pdf
National teletrials compendium: https://www.health.gov.au/resources/collections/the-national-teletrials-compendium
Queensland Health teletrials information page: https://www.health.qld.gov.au/hiiro/html/teletrials
Medicines Australia Teletrials Resource page: https://www.medicinesaustralia.com.au/policy/clinical-trials/tele-trials/